Product Reviewer (Notified Body)

• Permanent
• £65k - 90k per year + Bonus

Are you an experienced Product Assessor with a deep understanding of MDS technical documentation reviews? Are you ready to advance your career in a challenging and rewarding role within a globally recognized organization?

A major Notified Body Client of ours is seeking an Active Device Product Assessor to join their expert team. This client operates at the forefront of sustainability, quality, and integrity, enabling a safer and more interconnected world. Their identity will remain confidential during the recruitment process to maintain discretion.

Key Responsibilities:

In this role, you will:

• Conduct comprehensive reviews of technical documentation for Active/SaMD/AI/ML-based devices, ensuring compliance with EU regulations and standards.
• Collaborate with cross-functional teams to enhance efficiency and quality.
• Develop and deliver training sessions for internal and external stakeholders.
• Manage review projects to optimize outcomes, improve client satisfaction, and maintain regulatory compliance.
• Respond to and resolve queries related to technical documentation reviews.
• Meet key performance indicators (KPIs) individually and as part of the team.
• Continuously maintain personal competency in reviewing technical files and documentation.
• Deliver exceptional service across the organization’s global certification network.

Qualifications & Experience:

• A Bachelor’s degree in a relevant discipline (e.g., engineering or related sciences).
• At least 4 years of professional experience in healthcare products or related industries, including 2 years in Active Device and/or SaMD development, programming, and AI/ML applications.
• Comprehensive knowledge of Software Life Cycle processes, including requirement analysis, design, testing, validation, and problem resolution techniques.
• Familiarity with relevant standards such as IEC 62304, IEC 82304, IEC 81001-5-1, and IEC 62366.
• An in-depth understanding of AI regulations, standards, and tools/libraries.
• Excellent written English skills for technical report reviews.
• Desirable knowledge of Technical File codes MDS1009 and MDS0315 as per EU 2017/2185 regulations.

Why Consider This Opportunity?

This position offers:

• A flexible, remote working model to support your work-life balance.
• The chance to work for a globally recognized leader in the TIC industry.
• Access to continuous professional development through advanced training programs.
• Collaboration within a multinational team, gaining insights from colleagues across the globe.
• A competitive benefits package tailored to your needs.

If you are passionate about driving innovation and compliance in the healthcare product certification industry, we encourage you to apply for this exciting opportunity.

Please note: Due to the confidential nature of this search, additional details about the client will only be disclosed at later stages of the selection process.